The Position
Clinical Research Manager is a key role located at Tokyo, Japan and reporting directly to the Clinical Operations Senior Director.
The ideal candidate will serve as the line manager for Clinical Research staff, including Clinical Research Associates (CRA) and/or Trial Managers (TM), to ensure the successful implementation of clinical trials. This includes site selection, Institutional Review Board (IRB) applications, delivery of clinical supplies, monitoring, Source Document Verification (SDV), collection of Case Report Forms (CRFs)/Data Collection Forms (DCFs), drug accountability, and site closure in compliance with Good Clinical Practice (GCP) and Standard Operating Procedures (SOPs).
In this senior trial management role, the CRM will be responsible for leading an efficient and seamless clinical development process without compromising quality as a clinical leader of the project development team.
The CRM will select suitable investigators/institutions for projects and conduct trials according to plan. Additionally, the CRM will assist TM/CRAs in supervising high-quality monitoring activities, including recruiting, monitoring, CRF&DCF collection, etc., according to GCP and SOPs.
Key responsibilities include:
- Manage team members
- Ensure On-the-Job Training (OJT) of team members (CRA or TM) to improve and maintain quality
- Collaborate with colleagues to handle line-related issues for effective people development and a better working climate
- Organize and lead study teams appropriately and work with project teams to create plans for new project development, such as strategy planning, CDP preparation, etc.
- Design protocols based on Trial Outlines (TO) and translate protocols into Japanese
- Develop operation plans, including patient enrollment plans, CRF collection plans, and monitoring guidelines, with other CRMs
- Manage study team members and relevant staff to prepare, conduct, collect data, and perform QC checks on schedule
- Approve labels for Investigational Medicinal Products (IMPs) and assist CRAs with monitoring activities according to GCP and SOPs
- Identify causes of delays and provide solutions, offering advice and instructions to concerned staff
- Collaborate with ITM, Data Management, and Statistics Analysis to create Clinical Trial Reports (CTRs)
- Prepare and update Trial Master Files (TMFs) to secure document quality
- Cope with internal audits, GCP inspections, and paper reviews with other CRMs
- Submit notifications to governments or Pharmaceuticals and Medical Device Agency (PMDA) in a timely manner
Requirements
- Minimum 10 years of experience in clinical operations, working on GCP clinical trials as CRA or TM
- Similar experience as CRA or TM in a similar job within the pharmaceutical industry will also be considered
- Experience in the entire Clinical Trial Process (from Site Selection until Trial Closure)
- Communication level English (speaking and writing) and native-level Japanese are required
- Strong communication and presentation skills for smooth communication with global teams, Study Teams, CRAs, and TMs
- Leadership and people management experience preferred
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